Patients who received anti-arrhythmic drugs as first-line therapy had a recurrence rate of 72.1% compared with 54.5% in patients treated with RFA at 2 years. Patients treated with RFA had fewer symptomatic recurrences of Afib and better quality of life.

Adverse events occurred in 9% of the RFA group, including four cases of cardiac tamponade, as reported online in the Journal of the American Medical Association.

"Freedom from symptomatic [Afib] was 68% at the 2-year follow-up with 14% requiring a second procedure," Carlos A. Morillo, MD, of McMaster University in Hamilton, Ontario, and colleagues reported. "These findings highlight the fact that although ablation is effective, there are still approximately 50% of patients who have [Afib] recurrences 24 months after undergoing a single procedure.

"Ablation extends the time free of both symptomatic and asymptomatic [Afib] and significantly reduced the recurrence of repeated episodes, potentially having an effect on [Afib] progression."

Noting the 50/50 odds of recurrence, the authors emphasized that clinicians who offer RFA to patients with paroxysmal Afib should discuss the risks and benefits and should individualize treatment.

The author of an accompanying editorial said the results support current guidelines that recommend RFA after the failure of at least one trial of drug therapy for Afib, but leave the door open to first-line use in selected patients.

"In clinical practice, it is uncommon to find a patient who is eager to undergo catheter ablation without at least one trial of an anti-arrhythmic medication," said Hugh Calkins, MD, of Johns Hopkins Hospital.

Though recommended as first-line therapy for Afib, anti-arrhythmic drugs fail to prevent recurrences in more than half of cases, estimated at 46% at 6 to 12 months, according to studies and meta-analyses, the authors pointed out. Moreover, a substantial proportion of patients discontinue therapy because of adverse events.

A preliminary randomized trial comparing first-line therapy with RFA versus medication, demonstrated a lower rate of recurrence with RFA and provided support for use as first-line treatment of paroxysmal Afib. However, a recent Scandinavian trial showed no difference between first-line RFA and medication in patients with a high Afib burden.

In the current study, Morillo and colleagues continued the evaluation of first-line RFA for paroxysmal Afib in a randomized, multicenter clinical trial. Eligible patients had symptomatic recurrent paroxysmal Afib lasting more than 30 seconds, at least one Afib episode documented by surface ECG in the previous 6 months, and no history of anti-arrhythmic drug therapy.

The primary efficacy endpoint was the time to first recurrence of symptomatic or asymptomatic Afib, atrial flutter, or atrial tachycardia lasting more than 30 seconds, as documented by ECG or telephonic monitor. Secondary outcomes included the first documented episode of recurrence, repeated episodes of symptomatic or asymptomatic Afib, and quality of life at 1 year.

Investigators reported data for 127 patients, 66 of whom were randomized to RFA — which entailed circumferential pulmonary vein isolation — and 61 who were randomized to anti-arrhythmic drug therapy. In the drug therapy group, 69% of patients started treatment with flecainide and 25% with propafenone; 16% tried more than one drug during the first 90 days.

When the trial ended, the difference in the primary outcome translated into a 44% risk reduction in the RFA group (hazard ratio 0.56, 95% CI 0.35-0.90, P=0.02). The secondary endpoint occurred in 59% of the drug therapy group and 47% of the RFA group (HR 0.56, 95% C 0.33-0.95, P=0.03).

Quality of life did not differ significantly between groups at baseline or 12 months, but the magnitude of change from baseline to 12 months reached statistical significance (P=0.03) in the RFA group but not the drug group (P=0.25).

Serious adverse events occurred in 9% of the RFA group and 6% of the drug therapy group. There were no reports of deaths or strokes in either group.

The trial provided new information about the efficacy of RFA, and the results should serve as a reminder of the potential problems that can arise with an invasive procedure, Calkins said in the editorial.

Although the results demonstrated efficacy for first-line RFA, they likely will have a limited impact on clinical practice, at least for the time being, even after taking into account the subgroup of patients who prefer RFA from the outset.

"Clearly, we don't want to deprive or deny patients who consider the issues and say 'I really prefer an ablative strategy to taking anti-arrhythmic medications,'" Calkins told MedPage Today. "Certainly, those patients should be free to proceed with catheter ablation first line, but in my practice that's less than 5% of all the [Afib] ablations that I perform."

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